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Pre-Exposure Prophylaxis (PrEP)

FDA Approves Truvada PrEP for Adolescents

The U.S. Food and Drug Administration (FDA) has approved changes to the indications for the fixed-dose combination pill Truvada (emtricitabine and tenofovir disoproxil fumarate) that now allow Truvada to be used as pre-exposure prophylaxis (PrEP) for adolescents weighing at least 35 kg (about 77 pounds) who are at risk for HIV infection. Truvada was first approved for HIV PrEP in at-risk adults in 2012. According to drug-maker Gilead, FDA’s decision to allow the use of Truvada-based PrEP in adolescents is based on the findings of study ATN113, which examined the use of Truvada in HIV-negative adolescents 15 to 17 years old.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” noted study lead investigator Sybil Hosek of the Cook County Health and Hospital System's Stroger Hospital in Chicago. “In addition to traditional risk-reduction strategies, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.” CDC surveillance data indicate that adolescents and young adults 13 to 24 years old comprised 21% of all new HIV infections in the U.S. during 2016, and that 81% of those infections were among young men who have sex with men.

“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose of the advocacy organization NMAC. “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it, particularly among communities disproportionately impacted by the disease, including young Black and Latino men in the United States.”

PrEP Use and Access in the U.S. Military

HIV infection is a substantial health concern for U.S. military service members stationed throughout the world. Each year, about 350 new HIV infections are diagnosed among military service members, and the majority of those infections acquired within the United States. HIV infections in the U.S. military mirror those in the U.S. civilian population, with the highest rates of new diagnoses among men and Blacks or African Americans. Blacks are disproportionally affected, and most new diagnoses occur among MSM. To examine the use of PrEP among military service members, researchers from the Walter Reed National Military Medical Center and elsewhere examined military health system and service records and surveyed military health care providers to assess their HIV PrEP knowledge and attitudes.

Among 769 service members prescribed PrEP during the period from February 1, 2014 through June 10, 2016, 87% were MSM. In addition, 60% of those receiving PrEP obtained prescriptions from an infectious disease provider, 19% were Black men, and 42% were more than 28 years old. Nearly half (49%) of surveyed military health care providers self-rated their PrEP knowledge as poor, and only 29% reported ever having prescribed PrEP.

“Despite the universal access to care afforded to service members by the military health care system, there is a recognized need to improve and expand access to PrEP for those patients at highest risk for HIV infection. Currently, the availability of PrEP services is heterogeneous, based on the individual patient’s geographic location,” the report authors note. “New DoD [Department of Defense] policy is being developed to address identified gaps through initiatives to improve health care provider education and so ensure universal access to PrEP at the primary care level, and to standardize pharmacy and laboratory service delivery at all military treatment facilities.”

Treatment Guidelines for HIV and Opportunistic Infections (OIs)

Recent Updates to U.S. Guidelines for Testing HIV and OIs

In recent weeks, the U.S. Department of Health and Human Services (HHS) has published several updates to its guidelines for the treatment of HIV and opportunistic infections. A brief summary of changes to the guidelines, together with links to more detailed information, are provided below:

Recommended Caution Regarding the Use of Dolutegravir by Women and Girls - The HHS Antiretroviral Guidelines Panels have issued recommendations cautioning about the potential risks of using the integrase inhibitor dolutegravir by women and girls who are pregnant or of child-bearing potential. A recent study found some cases of neural tube defects among women who started a dolutegravir-based ART regimen prior to pregnancy and who were still receiving it at the time of conception.

The U.S. and Global HIV Epidemic

Continued Progress in Reducing HIV Infections and Improving Health Outcomes in the U.SThe U.S. has continued to make progress in reducing new HIV infections, improving health outcomes among people living with HIV, and reducing some HIV-related disparities, according to the 2017 National HIV/AIDS Strategy (NHAS) Progress Report. The report was produced by HHS’s NHAS Federal Interagency Workgroup, which is responsible for coordinating implementation and monitoring of the Strategy across the federal government.An important component of the NHAS is a series of 17 indicators that are used to measure U.S. progress in meeting the plan’s objectives. The NHAS workgroup was able to gather and present information on 16 of the indicators in the report. According to the report, the U.S. has met or exceeded the annual targets in nine categories and made significant progress toward meeting another two of those targets. Examples of recent progress include:

The number of new HIV diagnoses decreased by nearly 5% from 41,985 in 2011 to 39,876 in 2015.

The percentage of persons living with diagnosed HIV who were virally suppressed increased from 46% in 2010 to 58% in 2014.

The number of adults prescribed PrEP increased by more than 300% from 7,972 in 2014 to 33,273 in 2015.

“Unfortunately, the report also shows that progress has not been equal across all populations and regions,” according to a brief summary of the report on HIV.gov. “There continue to be disparities in HIV risk and diagnoses for gay and bisexual men, stable housing among people living with HIV, and HIV diagnoses in the Southern U.S.” 15-Year Highlights from PEPFARLast month marked the 15th anniversary of the enactment of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). At that time, only 50,000 people in Africa were receiving life-saving antiretroviral treatment (ART) for HIV infection, and death rates among persons living with HIV there were high and rising. Now PEPFAR supports more than 14 million men, women, and children on ART – more than twice the number 4.5 years ago. In addition, PEPFAR:

has enabled more than 2.2 million babies to be born HIV-free to HIV-positive mothers;

assists more than 6.4 million orphans, vulnerable children, and their caregivers affected by HIV/AIDS; and

has provided voluntary medical male circumcision to more than 15.2 million men and boys to prevent HIV transmission.

The latest PEPFAR data show at least a 25-40% decline in new HIV diagnoses among adolescent girls and young women in nearly two-thirds of the highest-HIV-burden communities that are implementing PEPFAR’s DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) public-private partnership across 10 African countries. “We have the historic opportunity – for the first time ever – to control a pandemic without a vaccine or a cure, laying the groundwork for eventually eliminating HIV,” notes Ambassador Deborah Birx, the U.S. Global AIDS Coordinator and Special Representative for Global Health. “Across Africa and in many other parts of the world, death and despair have been overwhelmingly replaced with hope and life.”

HIV Among Asians (CDC) – This fact sheet provides information on new HIV diagnoses, prevalence, and prevention challenges for Asian Americans, as well as steps that CDC is taking to address HIV among Asian Americans.

False-Positive HIV Results (CDC) – This fact sheet describes what false-positive results are, their causes, and additional tests that can be performed to distinguish true and false positives.

AIDSinfo has also recently released the following updated fact sheets on HIV prevention, with corresponding Spanish-language versions available on its infoSIDA site:

The University of North Carolina (UNC) Department of Medicine has recently produced a six-part “HIV Matters” series as part of its Chair’s Corner with Dr. Ron Falk podcast. The HIV Matters audio podcasts, which are available on the Soundcloud platform, feature 20- to 30-minute interviews with prominent HIV researchers and cover the following topics:

preventing HIV with PrEP;

getting care for HIV;

HIV treatment;

living a long life with HIV;

HIV-related challenges facing women and minorities; and

participating in HIV cure research.

Flipchart on Transitioning Adolescents from Pediatric to Adult HIV Care

As part of its TREAT Asia initiative, amfAR has developed tools to help providers manage the transition of adolescents from pediatric to adult HIV clinics. Among these tools is the 34-slide illustrated flipchart Transferring Care, which providers can use to guide their discussions with young patients transitioning to adult care. This resource includes information on the following topics:

differences between pediatric and adult HIV clinics;

when to make the transition in care;

what to expect at an adult HIV clinic; and

general information about HIV treatment and prevention.

The flipchart is currently available for download in English, Bahasa Indonesia, Khmer, Thai, and Vietnamese. A Malay version is expected to be released in September 2018.